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Clinical Trial NCT03260400 for Amputation Neuroma, Amputation is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Short-term Implanted Electrodes Following Regenerative Peripheral Nerve Surgery for Improving Prosthetic Limb Control Signals 10 Short-Term

Recruiting
Clinical Trial NCT03260400 is an interventional study for Amputation Neuroma, Amputation that is recruiting. It started on December 11, 2017 with plans to enroll 10 participants. Led by University of Michigan, it is expected to complete by May 5, 2029. The latest data from ClinicalTrials.gov was last updated on August 26, 2025.
Brief Summary
The device, a bipolar percutaneous intramuscular electromyography electrode, is intended for use in upper-limb amputation patients who have received the regenerative peripheral nerve interface surgical procedure, in order to enable the use of advanced prosthetic arms and hands.
Detailed Description
This is a single center, 10 subject early feasibility study in which the primary objective is to ensure the safety of percutaneous intramuscular electrodes implanted in surgically-created RPNI constructs (free muscle grafts attached to the amputated nerves) in subjects with upper limb amputation. The secondary objectives are to assess the efficacy of the electrodes in recording electromyographic signals from the RPNI...Show More
Official Title

Short-term Implanted Electrodes Following Regenerative Peripheral Nerve Surgery for Improving Prosthetic Limb Control Signals

Conditions
Amputation NeuromaAmputation
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
NCT ID Number
NCT03260400
Start Date (Actual)
2017-12-11
Last Update Posted
2025-08-26
Completion Date (Estimated)
2029-05-05
Enrollment (Estimated)
10
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
RPNI
Regenerative Peripheral Nerve Interface
Primary Purpose
Device Feasibility
Design Allocation
Non-Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalNew Grafts
In this arm, participants will have an initial surgery to place partial muscle grafts on the amputated nerves. After a healing period, the participant will have a shorter surgical procedure to implant the electrodes onto the muscle grafts and in residual muscles. After another healing period, experiments with prosthetic control and sensory feedback will begin.
a bipolar percutaneous intramuscular electromyography electrode
The device, a bipolar percutaneous intramuscular electromyography electrode, is intended for use in upper-limb amputation patients who have received the regenerative peripheral nerve interface surgical procedure, in order to enable the use of advanced prosthetic arms and hands.
ExperimentalExisting Grafts
In this arm, participants have already had partial muscle grafts placed on the amputated nerves to control neuroma growth. The participant will have a short surgical procedure to implant the electrodes onto the muscle grafts and in residual muscles. After a healing period, experiments with prosthetic control and sensory feedback will begin.
a bipolar percutaneous intramuscular electromyography electrode
The device, a bipolar percutaneous intramuscular electromyography electrode, is intended for use in upper-limb amputation patients who have received the regenerative peripheral nerve interface surgical procedure, in order to enable the use of advanced prosthetic arms and hands.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Change in Pain Level as measured by SF-36
Pain will be assessed using the SF-36 survey instrument, to be filled out by the participant before and after each surgical procedure performed and at a minimum of once per month while electrodes remain implanted. Two questions related to pain with a score closer to 0 means a pain increase
Baseline and monthly for up to 7 years postoperatively
Change in Pain Level as measured by LANSS survey
Pain will be assessed using the LANSS survey instrument, to be filled out by the participant before and after each surgical procedure performed and at a minimum of once per month while electrodes remain implanted. A score greater than 12 indicates neuropathic pain.
Baseline and monthly for up to 7 years postoperatively
Change in Pain Level as measured by Phantom Limb Questionnaire
Phantom pain will be assessed using the Phantom Limb Questionnaire, to be filled out by the participant before and after each surgical procedure performed and at a minimum of once per month while electrodes remain implanted. This 9-item instrument measures phantom pain on a scale of 0-4, where 0-no pain at all and 4=very severe pain.
Baseline and monthly for up to 7 years postoperatively
RPNI tissue degeneration measured by pain scores
RPNI tissue degeneration will be assessed by changes in pain scores (see above) and measurements of recording efficacy. Recording efficacy will be assessed using two signal quality measures: 1. Peak-to-peak signal amplitude during maximum voluntary contraction 2. Signal-to-noise ratio during maximum voluntary contraction
Baseline and once per month after surgery following a 3-month postoperative recovery period, while electrodes remain implanted.
RPNI electrode migration assessed by changes recording in efficacy and ultrasound
Electrode migration outside of the implanted RPNI graft or muscle will be assessed by changes in recording efficacy, as described above, and by ultrasound examination as necessary. Electrode extrusion and implantation complications will be assessed by adverse events reported by both the participant and the study physicians. At each study visit, the participant will be asked to report any issues, and will have a basic examination of the affected limb performed by study physicians and/or trained staff.
Baseline and once per month after surgery following a 3-month postoperative recovery period, while electrodes remain implanted.
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
EMG signal quality from RPNI grafts
Efficacy will be assessed, for each implanted electrode using two calculated signal quality measures: Peak-to-peak signal amplitude during maximum voluntary contraction and signal-to-noise ratio during maximum voluntary contraction.
Baseline and monthly for up to 7 years postoperatively
Stimulation Threshold of RPNI grafts
Stimulation data will be recorded at least once per month while electrodes remain implanted. Stimulation threshold will be determined using the range of sensory feedback necessary to evoke a sensory percept.
Baseline and monthly for up to 7 years postoperatively
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
22 Years
Eligible Sexes
All
  • Participants must be 22 years of age or older.
  • Participants must have previously undergone an upper limb amputation proximal to the wrist.
  • For participants without existing RPNI grafts (at the time of enrollment), the residual limb must have sufficient soft tissue quality to support performance of the RPNI operative procedure. Participants sustaining severe crushing or avulsion injuries with substantial superficial and deep scarring may not be appropriate candidates for inclusion in the study.
  • Participants must be in good health and American Society of Anesthesiologists (ASA) Class I or II (low surgical risk).
  • Participants must have reliable transportation.
  • Participants must be able to attend at minimum 2 visits per month while electrodes remain implanted.
  • Participants must be at least 6 months post-amputation.

  • Participants may not be suffering from any severe pain syndrome including complex regional pain syndrome or severe phantom pain. All of these conditions would suggest pathological activity of the nerve and would exclude the participant from participation.
  • Participants must not be suffering from any untreated mental health disorders and if they have any DSM-5 diagnoses, they must receive approval to participate from their mental health professional.
  • Participants must not have any medical conditions that, in the opinion of the Principal Investigator, would place them at high risk for a surgical procedure including recent myocardial infarction, cerebrovascular accidents, deep venous thrombosis, pulmonary embolus, uncontrolled diabetes, or end stage renal disease.
  • Participants must not have used tobacco for at least one month prior to enrollment in the study.
  • Participants must agree to not use tobacco for the duration of the study.
  • Participants cannot have sustained bilateral upper extremity amputation.
  • Participants cannot be pregnant.
  • Participants must not have other indwelling electronic implants like pacemakers, implantable cardioverter defibrillators, implantable neurostimulators, body worn insulin pumps, or body worn patient monitoring devices.
  • Participants must not have severe peripheral vascular occlusive disease, venous hypertension of the extremity, or severe lymphedema of the extremity.
  • Participants must not have an autoimmune condition which is not well controlled by medication.
  • Participants will not be considered for enrollment in Primary Upper Limb Amputation with RPNI Grafts and Electrode Implantation if their amputation is a traumatic injury or cancer related
University of Michigan logoUniversity of Michigan489 active studies to explore
National Institute of Neurological Disorders and Stroke (NINDS) logoNational Institute of Neurological Disorders and Stroke (NINDS)325 active studies to explore
Study Responsible Party
Paul Cederna, Principal Investigator, Robert Oneal Professor and Chief of Plastic Surgery; Professor, Biomedical Engineering, University of Michigan
Study Central Contact
Contact: Paul Cederna, M.D., 734-936-5885, [email protected]
Contact: Jenni Hamill, MPH, 734-936-5885, [email protected]
1 Study Locations in 1 Countries

Michigan

University of Michigan, Ann Arbor, Michigan, 48109, United States
Paul Cederna, M.D., Contact
Recruiting